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What is the most important information I should know about UZEDY?

UZEDY can cause serious side effects, including an increased risk of death in elderly people who are confused, have memory loss, and have lost touch with reality (dementia-related psychosis). UZEDY is not approved for use in patients with dementia-related psychosis.

Do not receive UZEDY if you are allergic to risperidone, paliperidone, or any of its components.

UZEDY may cause serious side effects, including:

  • Stroke in elderly people (cerebrovascular problems) that can lead to death.
  • Neuroleptic Malignant Syndrome (NMS). NMS is a rare but very serious problem that can lead to death. Seek medical attention right away if you have any of these symptoms: high fever, severe muscle stiffness, confusion, sweating, irregular heartbeat, fast heart rate, or changes in your blood pressure.
  • Uncontrolled facial or body movements (tardive dyskinesia) that may not go away, even if you stop receiving UZEDY. Tardive dyskinesia may also start after you stop receiving UZEDY.
  • Problems with your metabolism that may include high blood sugar (hyperglycemia), diabetes mellitus, changes in the fat levels in your blood (dyslipidemia), and weight gain. Extremely high blood sugar can lead to coma or death. If you have diabetes or are at risk for diabetes (e.g., obesity, family history of diabetes), your healthcare provider should check your blood sugar before you start and during treatment with UZEDY. Call your healthcare provider if you have symptoms of high blood sugar including: feeling very thirsty, hungry, sick to your stomach, weak or tired, or confused; needing to urinate more than usual; or your breath smells fruity.
  • High levels of prolactin in your blood. UZEDY may cause a rise in the blood levels of a hormone called prolactin that may cause side effects including missed menstrual periods, decreased fertility in women, leakage of milk from the breasts, development of breasts in men, or problems with erection.
  • Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.
  • Falls. Antipsychotic medicines like UZEDY may cause drowsiness or dizziness when you are standing, which could increase your risk for falls and related injuries.
  • Low white blood cell count.
  • Problems thinking clearly and moving your body. Do not drive, operate machinery, or do other dangerous activities until you know how UZEDY affects you.
  • Seizures (convulsions).
  • Difficulty swallowing that can cause food or liquid to get into your lungs.
  • Prolonged or painful erection lasting more than 4 hours. Call your healthcare provider or go to your nearest emergency room right away if you have an erection that lasts more than 4 hours.
  • Problems with control of your body temperature (too high or too low). Avoid getting overheated or dehydrated.

The most common side effects of risperidone included slow movements, stiffness, shaking, restlessness, abnormal muscle contractions or movements, drowsiness, dizziness, anxiety, blurred vision, nausea, vomiting, indigestion, diarrhea, increased saliva, constipation, dry mouth, increased appetite, weight gain, tiredness, rash, and common cold symptoms. Injection site reactions including a lump or itching were reported with UZEDY. These are not all the possible side effects of UZEDY. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. For more information, ask your healthcare provider or pharmacist.

Do not drink alcohol during treatment with UZEDY.

Before receiving UZEDY, tell your healthcare provider about all your medical conditions, including if you:

  • have had Neuroleptic Malignant Syndrome.
  • have or have had uncontrolled movements of your tongue, face, mouth, or jaw (tardive dyskinesia).
  • have diabetes or have a family history of diabetes.
  • have had dizziness or fainting or are being treated for high blood pressure.
  • have had a low white blood cell count.
  • have or have had seizures or epilepsy.
  • are pregnant or plan to become pregnant during treatment with UZEDY. It is not known if UZEDY will harm your unborn baby. Use of UZEDY during the third trimester of pregnancy may cause side effects in the newborn infant, including agitation, abnormal muscle tone, tremor, drowsiness, difficulty feeding, and difficulty breathing. Seek medical attention if you notice these signs. If you become pregnant during treatment with UZEDY, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics, or call 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.
  • are breastfeeding or plan to breastfeed. If you are receiving UZEDY and are breastfeeding, monitor your infant for sleepiness, inadequate weight gain, jitteriness, tremors, and abnormal muscle movements. Seek medical care if you notice these signs.
  • have or have had kidney or liver problems.

Tell your healthcare provider about all the medicines you take or plan to take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. UZEDY and other medicines may affect each other.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.


UZEDY (risperidone) extended-release injectable suspension is a prescription medicine used to treat schizophrenia in adults.

For more information about UZEDY, see the full Prescribing Information, including Boxed WARNING, or talk to your healthcare provider.